Ibuprofen-BP

Ibuprofenum

Ibuprofen-BP 200 mg film-coated tablets: one tablet contains ibuprofen 200 mg. Ibuprofen-BP 400 mg film-coated tablets: one tablet contains ibuprofen 400 mg.

Indication: Short-term symptomatic treatment of mild to moderate pain and fever, including pain and feverish conditions associated with the common cold.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications − Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. − Patients who have experienced hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. − Active gastric or duodenal ulcer, or history of recurrent peptic ulceration/gastrointestinal haemorrhage (two or more distinct episodes of proven ulceration or bleeding). − History of gastrointestinal bleeding or perforation related to previous NSAID therapy. − Severe heart failure (NYHA Class IV), severe renal or hepatic impairment (see section 4.4). − Haemorrhagic diathesis and coagulation disorders. − Severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake). − Cerebrovascular haemorrhage or other active bleeding. − Children under 12 years of age − Last trimester of pregnancy (see section 4.6).

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use Adverse reactions can be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 and the GI/cardiovascular risks described below). Administration of doses higher than recommended carries serious risks. Ibuprofen-BP should be administered only after careful evaluation of the benefit-risk ratio in the presence of the following: − Congenital disorder of porphyrin metabolism (e.g. acute intermittent porphyria) − First and second trimester of pregnancy (see section 4.6) − Breast-feeding (see section 4.6) The following situations require special caution: − Gastrointestinal disorders, including chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease). − Heart failure or hypertension − Reduced renal function − […]